The “Building Resilient Research Ethics, Diagnostics and Medicines regulatory capacity during routine and public health emergency periods” by acronym “BREEDIME”.

From July 2023, TMDA, as Scientific Lead, has been implementing a 36-month Project called “Building Resilient Research Ethics, Diagnostics, and Medicines Regulatory capacity during routine and public health emergency periods” by the acronym “BREEDIME” under EDCTP3 Global Health Funding. The Project is implemented by a total of nine (9) consortium members, including Zanzibar Food and Drugs Agency (ZFDA), Rwanda Food and Drugs Authority (Rwanda FDA), Kilimanjaro Christian Research Institute (KCRI), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Health Research Institute (ZAHRI), The University Court of The University of St. Andrew (UStAn), United Kingdom and Karolinska Institutet (KI), Sweden.

The Main Objective of the Project
To strengthen clinical trials oversight, ethical review processes, and post-marketing surveillance of therapeutics, vaccines, diagnostics, and critical medical devices.

The Specific Objectives of the Project

1. To build capacity for rapid evaluation of therapeutic or vaccine trial protocols during a public health emergency;
2. To strengthen the regulatory framework and capacity to evaluate clinical trials for in vitro diagnostic and critical medical devices;
3. To establish a regulatory and ethical framework for health data access and sharing in normal and public health emergency periods
4. To strengthen capacity for post-market evaluation and appraisal of medicines and medical devices.
5. To create South-South benchmarking and mentorship on clinical trials oversight and medicines regulatory capabilities.

Project Implementation Progress: -

The Project has a total of 26 deliverables, and 19 deliverables have been completed, while seven (7) are ongoing. The implemented deliverables are: -

1. Launching of the project.
2. Establishment of Project Website.
3. Guidance and or algorithm in response to Evaluation and comments during an emergency outbreak in place.
4. Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency.
5. Baseline assessment for performance evaluation of diagnostics and critical medical devices.
6. Guidance documents for applicants and manufacturers on conducting a performance evaluation of diagnostic test kits.
7. Developing specific protocols for conducting performance verification studies for selected diagnostic test kits used for testing COVID-19, HIV, Hepatitis, Syphilis, TB and Malaria.
8. Performance evaluation of diagnostics and critical medical devices.
9. Data management Plan developed.
10. Update the Data Management Plan developed.
11. Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market.
12. Sample collection and product information review (PIR).
13. Training needs assessment for therapeutic and vaccine protocol evaluation.
14. Preparation of training curriculum and materials for assessors.
15. Training of clinical trial assessors on in vitro diagnostics and medical device clinical trial evaluation.
16. Training on rapid evaluation of therapeutic or vaccine trial protocol during a public health emergency.
17. Customization of a short ethics course for the Rwanda FDA.
18. Exploitation and Dissemination Plan.
19. Updated Exploitation and Dissemination Plan.

The ongoing deliverables are: -

1. Awareness creation on the existence of the BREEDIME project.
2. Joint evaluation of clinical trial applications.
3. Post-approval joint inspections of clinical trial sites.
4. Monitoring and evaluation of the project.
5. Stakeholders' forum for dissemination of Project reports.
6. Establishing a regulatory framework on health data and material sharing during the emergency periods.
7. Regulatory capacity building, sharing scientific experience within the consortium countries.

Bioethics Training Workshop at Rwanda Food and Drugs Authority (Rwanda FDA), facilitated by Kilimanjaro Clinical Research Institute (KCRI), Tanzania - 22nd April 2024, Opening Day.

Trainers and Participants with their Certificates during the last day of training on the Bioethics course in Rwanda on April 26, 2024.

Project Launching, Landmark Hotel, Dar es Salaam.

Group Photo of TMDA Director General (fourth from the right – front) and training Participants – during training of assessors on clinical investigation of medical devices, Morogoro.